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New Tri-Specific antibody takes on Hard-to-Treat myeloma

NCT ID NCT06375044

Disease control Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This early-stage trial tests a new drug called SIM0500 in 130 adults with multiple myeloma that has returned or stopped responding to treatment. SIM0500 is a tri-specific antibody designed to help the immune system attack cancer cells. The study will first find the safest dose, then test that dose more closely, while monitoring side effects and any tumor shrinkage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SIM0500 (a tri-specific antibody targeting GPRC5D, BCMA, and CD3 proteins)
What this could lead to
If successful, this could lead to a new treatment option for patients with multiple myeloma that has stopped responding to standard therapies.
What could go wrong
This is an early Phase 1 trial with only 130 participants, so safety and effectiveness are not yet proven. Side effects from the immune system activation are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 130 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Voluntary participation and signature of informed consent form. 2. ≥18 years of age. 3. Have documented diagnosis of relapsed or refractory multiple myeloma according to Criteria for Response to Multiple Myeloma Treatment(IMWG)diagnostic criteria who have failed all established standard of care. 4. Life expectancy ≥12 weeks. 5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1. 6. Adequate hematologic, hepatic, and renal function. Exclusion Criteria: 1. Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy. 2. Active hepatitis B (HBsAg positive and HBV DNA ≥ 1×104 copies/mL or ≥ 2,000 international unit \[IU\]/mL) or hepatitis C (HCV antibody positive and HCV RNA ≥ ULN) infection; participant with HBsAg positive or detective HBV-DNA at screening should receive antiviral treatment as per local practice during the trial. 3. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS). 4. Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial. 5. Active known or suspected autoimmune disease. Participants with vitiligo, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger, type 1 diabetes mellitus (blood glucose can be controlled by insulin therapy) can be included. 6. Current or previous other malignancy within 3 years of study entry, except basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast. 7. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. 8. Participants with known active infection within 14 days prior to the first SIM0500.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma Recurrence refractory plasma cell neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed or refractory multiple myeloma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    16 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Beijing Chaoyang Hospital Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100000, China

  • Dana Farber Cancer institution

    RECRUITING

    Boston, Massachusetts, 02215, United States

    Contact Email: •••••@•••••

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450000, China

  • Icahn School of Medicine at Mount Sinai，The Tisch Cancer Institute

    RECRUITING

    New York, New York, 10029, United States

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Tianjin, Tianjin Municipality, 300000, China

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Mayo Clinic Arizona

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjing, Jiangsu, 210008, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510000, China

  • Tennessee Oncology

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • The First Affiliated Hospital Zhejiang University School of Medicine

    RECRUITING

    Hanzhou, Zhejiang, 310000, China

  • The First Affiliated Hospital of FuJian Medical University

    RECRUITING

    Fuzhou, Fujian, 350005, China

  • UC Irvine Health

    RECRUITING

    Orange, California, 92868, United States

  • University of North Carolina Hospitals at Hillsborough

    RECRUITING

    Hillsborough, North Carolina, 27278, United States

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